Menlo Care, Inc.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Menlo Care, Inc.” (first 1986, latest 1997), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 115 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 22 | 22 |
| DYB | Introducer, Catheter | 2 | 2 |
| FAD | Stent, Ureteral | 2 | 2 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
| KMK | Device, Intravascular Catheter Securement | 1 | 1 |
| LJE | Catheter, Nephrostomy | 1 | 1 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Menlo Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964447 | PICC CATHETER/MIDLINE CATHETER | LJS | 1997-04-16 | 161 |
| K951620 | MIDMARK MIDLINE CATHETER | FOZ | 1996-04-04 | 363 |
| K945521 | CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY | FOZ | 1995-04-06 | 147 |
| K950737 | LANDMARK MIDLINE CATHETER | FOZ | 1995-03-29 | 41 |
| K944968 | LANDMARK MIDLINE CATHETER | FOZ | 1995-03-29 | 169 |
| K943893 | PERCUTANEOUS GRAINAGE CATHETER | LJE | 1995-03-07 | 210 |
| K943143 | BILIARY STENT | FGE | 1995-02-28 | 243 |
| K930048 | SAFE-PICC CATHETER | FOZ | 1994-05-12 | 492 |
| K933941 | MENLO CARE URINARY DIVERSION STENT | FAD | 1994-03-31 | 231 |
| K940127 | CENTERMARK SECURING WINGS | KMK | 1994-02-09 | 30 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Menlo Care, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Menlo Brands, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Menlo Care, Inc.?
FDA lists 31 510(k) clearances under the applicant name “Menlo Care, Inc.” (first 1986, latest 1997), across 8 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Menlo Care, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Menlo Care, Inc. is 115 days.
Which FDA product codes appear under Menlo Care, Inc.?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 22); DYB (Introducer, Catheter, 2); FAD (Stent, Ureteral, 2).
Next steps
- See all 31 Menlo Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Menlo Care, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.